Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations
NCT ID: NCT04509115
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1709 participants
OBSERVATIONAL
2020-09-11
2023-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Specific aims
1. To assess patients' pain and opioid use patterns in episodes of acute pain for which opioids were prescribed, characterizing pain severity and persistence, as well as other prescription and over-the-counter pain medication use
2. To examine associations between patient demographic, clinical and emotional characteristics and outcomes of pain severity and persistence, opioid and non-opioid treatment patterns, satisfaction with care, and barriers to care
3. To assess how patients handled unused opioids
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients given short-acting opioid prescription
Patients not currently using opioids who receive a new short-acting opioid prescription for acute pain will be recruited.
Short-acting opioid prescription for acute pain
Patients not currently using opioids who receive a new short-acting opioid prescription as part of routine care for acute pain will be recruited and followed prospectively for 180 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Short-acting opioid prescription for acute pain
Patients not currently using opioids who receive a new short-acting opioid prescription as part of routine care for acute pain will be recruited and followed prospectively for 180 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Experiencing acute pain of less than 8 weeks duration at the time the opioid is prescribed
* Received prescription for opioid analgesic at visit; opioids included in the study will be all FDA-approved enteral, transdermal, and transmucosal opioid analgesics including the most common: hydrocodone (except cough and anti-diarrheal medications), oxycodone, codeine (except cough medications), tramadol, morphine, hydromorphone. Receipt of a prescription for the following is not an exclusion: buprenorphine (as an analgesic), butorphanol, dihydrocodeine, fentanyl, meperidine, methadone (as an analgesic), oxymorphone, pentazocine, sufentanil, and tapentadol. All of these opioids are included in any combinations with acetaminophen, aspirin, ibuprofen, naloxone, etc.
* Self-report of no opioid use (no use of prescribed opioids or illicit opioids, including medical or non-medical use) in the past 6 months
* Willing and able to give consent and participate in study
* Able to access a device with web access (laptop, desktop, smartphone, or tablet) daily to complete study surveys
* Willing to connect Fitbit to a mobile device (smartphone or tablet) that can regularly link to Hugo for data transfer
* Willing to use the health data sharing platform
* Released/discharged to home after their visit.
Exclusion Criteria
* Cancer or end-of-life pain;
* Unable to give consent and be enrolled within 3 days of their visit.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Food and Drug Administration (FDA)
FED
Yale University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joseph Ross, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama Birmingham
Birmingham, Alabama, United States
Cedars Sinai
Los Angeles, California, United States
Yale-New Haven Health
New Haven, Connecticut, United States
Mayo Clinic
Rochester, Minnesota, United States
Monument Health
Rapid City, South Dakota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jeffery MM, Ahadpour M, Allen S, Araojo R, Bellolio F, Chang N, Ciaccio L, Emanuel L, Fillmore J, Gilbert GH, Koussis P, Lee C, Lipkind H, Mallama C, Meyer T, Moncur M, Nuckols T, Pacanowski MA, Page DB, Papadopoulos E, Ritchie JD, Ross JS, Shah ND, Soukup M, St Clair CO, Tamang S, Torbati S, Wallace DW, Zhao Y, Heckmann R. Acute pain pathways: protocol for a prospective cohort study. BMJ Open. 2022 Jul 5;12(7):e058782. doi: 10.1136/bmjopen-2021-058782.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2000027561
Identifier Type: -
Identifier Source: org_study_id